A comparative evaluation of bioequivalence of Gan & Lee glargine U300 and Toujeo^® in Chinese healthy male participants.

ABSTRACT:

Background

To assess the bioequivalence between Gan & Lee (GL) glargine U300 and Toujeo^® regarding pharmacokinetics (PK), pharmacodynamics (PD), and safety in Chinese healthy male participants.

Methods

A single-center, randomized, double-blind, single-dose, two-preparation, two-sequence, four-cycle repeated crossover design study was performed to compare GL glargine U300 and Toujeo^® in 40 healthy participants. The primary PK endpoints were the area under the curve of glargine metabolites, M1 concentration from 0 to 24 hours (AUC_0-24h), and the maximum glargine concentration within 24 hours post-dose (C_max). The primary PD endpoints were the area under the glucose infusion rate (GIR) curve from 0 to 24 hours (AUC_GIR.0-24h

SUBMITTER: Li X 

PROVIDER: S-EPMC11337195 | biostudies-literature | 2024

REPOSITORIES: biostudies-literature